ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
13 August 2007
Application Code
HSC07017
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (the Act)
Applicant
AgResearch Limited
Purpose of the Application
AgResearch dicyandiamide device: to field trial in containment a
sustained slow release device containing dicyandiamide (DCD) that
is applied into urine patches of grazing livestock (field trial).
Date Application Received
25 June 2007
Consideration Date
10 August 2007
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1 Summary of Decision
1.1
The containment application to import or manufacture the substance identified as,
AgResearch dicyandiamide device, for the purposes of conducting field trials, is approved
with controls in accordance with the relevant provisions of the Act and the HSNO
(Methodology) Order 1998 (the Methodology).
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
AgResearch dicyandiamide device
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 31. The decision was determined in
accordance with section 32, taking into account additional matters to be considered in
that section and matters specified under Part II of the Act and the provisions of Part
III of the Third Schedule of the Act. Unless otherwise stated, references to section
numbers in this decision refer to sections of the Act.
2.2
Consideration of the application followed the relevant provisions of the Methodology.
Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3 Application process
3.1
The application was formally received on 25 June 2007.
3.2
Project Team:
Brendon Noonan
Advisor (Hazardous Substances)
Sekove Tinalevu
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit.
Report review and sign-out by:
Beth Dye
Applications Manager (Hazardous Substances).
3.3
The applicant supplied the following documents:
 the application; and
 confidential appendices including formulation data, supplementary commercially
sensitive details regarding the substance’s lifecycle and presentation, the OECD
SIDS document for dicyandiamide, ACVM approval documents and background
documentation on soil nitrification losses.
3.4
The following government departments were advised of the receipt of the application
(in accordance with clause 2(2)(e)) and given the opportunity to comment:
 the Department of Labour (Workplace Group);
 the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)); and
 the Ministry of Health.
3.5
No responses were received.
3.6
A request for more information was issued under section 58 of the Act on 03 August
2007. The requested information was supplied on 09 August 2007. The information
supplied was reviewed and considered sufficient to proceed with the assessment.
3.7
The applicant was provided with a copy of the proposed controls for AgResearch
dicyandiamide device and given the opportunity to comment on them. The comments
provided were taken into account in the setting of controls.
4 Consideration
Sequence of the consideration
4.1
This application was considered by the Chief Executive of ERMA New Zealand under
delegated powers from the Authority (section 19(2)(e)).
4.2
In accordance with section 32, the approach adopted when considering this application
was to confirm whether the application was for one of the purposes specified in
section 30, to identify and assess the risks and to determine whether the substance
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could be adequately contained by controls to provide for each of the matters specified
in Part III of the Third Schedule of the Act.
Purpose of the application
4.3
The purpose of the application is to enable AgResearch Limited to manufacture and
field trial a slow release device containing dicyandiamide (DCD). The trials will be
conducted to optimise the release rate of the carrier matrix and determine the quantity
of DCD required to effectively inhibit nitrogen leaching from soil urine patches of
grazing animals.
4.4
The Project Team considers that the purpose of the application amounts to “research
and development” on the identified substance and therefore the application qualifies
for consideration under section 30(ba).
Lifecycle
4.5
The applicant, AgResearch Limited has stated that the DCD component of the device
will be imported into New Zealand and the slow release admixture will be formulated
by Argenta Limited, an Auckland based company. The blending of the admixture and
the DCD will also be carried out by Argenta Limited. The concentration of DCD in
the trial substance will vary between 25 and 70 percent weight by weight (w/w).
4.6
The applicant intends to trial the substance, primarily, at their Palmerton North and
Hamilton research centres. Field trials will also be carried out at various AgResearch
farms and other farms contracted to AgResearch throughout New Zealand.
4.7
The substance will be applied into urine patches of grazing livestock, some of which
may be food producing. Due to the novel nature of the application technique being
used detail has not been released by the applicant for commercial reasons. For
assessment purposes details are provided in confidential Appendix 2. The substance’s
presentation and application technique are expected to limit human exposure to the
substance.
4.8
The applicant has indicated that the application of DCD into the environment will be
significantly less than that applied when DCD is used conventionally, i.e. broadcast
application as a slurry or granule.
4.9
Any unused quantities of the substance will be returned to AgResearch Limited at the
completion of the trials.
Hazardous properties
4.10
The Project Team notes that a containment application only requires sufficient
understanding of the hazardous properties to ensure that any risks can be managed by
the containment controls. The scope of the hazard information will often be limited
for containment applications, as the substance will be experimental and data on its
hazardous properties may not be available.
4.11
The applicant has provided an assessment of the hazards posed by DCD but not for
the formulation as a whole. The Project Team notes that the hazards posed by DCD
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are reasonably well understood and the component is covered by existing approvals in
New Zealand. While DCD only triggers hazard classifications for ecotoxicity the
Project Team notes that another component in the formulation triggers a range of
both toxicity and ecotoxicity classifications. Given the lack of data on the formulation
and the hazard thresholds triggered by individual components the Project Team
considers that the substance has the potential to cause adverse affects within the
environment and to human health.
4.12
The Project Team has reviewed the information supplied by the applicant and other
information available to it and considers that there is sufficient information to
determine that any risks posed within the defined lifecycle of the substance in New
Zealand can be adequately managed through the application of controls.
Identification and evaluation of the significant risks of the substance in
containment
4.13
The applicant has identified and assessed potential risks and detailed proposals for, and
impacts of, risk management. The Project Team has reviewed the applicant’s
assessment of the risks to the environment, human health and welfare and Māori
issues and concerns as set out below:
Risks to the environment
4.14
If released into the environment, the substance has the potential to result in adverse
effects within the environment.
4.15
On the basis of the lifecycle of the substance, adverse environmental effects could
arise from:
 an accident during storage, use or transportation, resulting in release of the
substance;
 failure to follow the correct operational procedures as set out in the controls and
containment system as described in the application, resulting in release of the
substance; or
 failure to follow correct disposal procedures.
4.16
The Project Team notes that limited quantities of the substance will be manufactured
and released into containment for field trials (i.e. up to 100 litres or kg depending on
the substance’s physical form). The Project Team also notes that DCD may, at
present, be applied in bulk as a fertiliser additive to pasture.
4.17
The Project Team considers that, taking into account the hazardous properties of the
substance, the quantities involved, the containment controls in Appendix 1 and
controls in place under other legislation, there are no significant risks to the
environment from this trial.
Risks to human health and welfare
4.18
The Project Team considers that adverse effects to human health and welfare may
result from exposure(s) to the substance, given the level of detail provided and the
related uncertainty.
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4.19
On the basis of the lifecycle of the substance outlined in paragraph 4.5-4.9, adverse
effects could arise from:
 an accident during storage, use or transportation, resulting in release of the
substance;
 failure to follow the correct operational procedures as set out in the controls and
the containment system, resulting in personnel exposure while contained, or
bystander exposure if released; or
 failure to follow correct disposal procedures.
4.20
The Project Team notes that the substance’s presentation is expected to reduce the
potential for human exposure during its handling; however, exposure is still possible
during its manufacture and packaging.
4.21
The Project Team considers that there are no significant risks to human health and
welfare, given the likely properties of the substance, the quantities involved, the
containment regime proposed by the applicant, the containment controls in
Appendix 1 and controls in place under other legislation.
Māori issues and concerns
4.22
The Project Team has considered this application in accordance with clauses 9(b)(i)
and 9(c)(iv) and sections 6(d) and 8. In addition, the Project Team used the
framework contained in the ERMA New Zealand user guide “Working with Māori
under the HSNO Act 1996” to assess this application.
4.23
In its assessment the Project Team has not identified any likely impacts that this
substance could have on Māori in terms of culture, traditional relationships with
ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. The
Project Team has no evidence to suggest that the controlled containment trial use of
the substance will breach the principles of the Treaty of Waitangi and therefore sees no
requirement for the applicant to consult with Māori regarding this application.
4.24
This assessment is made on the condition that the substance is handled, blended,
stored, transported, used and disposed of, in accordance with the explicitly stated
HSNO controls, and any controls stipulated in other applicable Acts. However,
should inappropriate use, or an accident, result in the contamination of water bodies or
the environment, it is suggested that the applicant notify the appropriate authorities
including the relevant iwi authorities in that region. This action should include
advising them of the contamination and the measures taken to contain and remedy it.
5 Containment and controls
5.1
The Project Team has evaluated the adequacy of the containment arrangements
proposed by the applicant and the controls listed in Appendix 1, and notes that these
cover the matters set out in Part III of the Third Schedule of the Act, being:
 to limit the likelihood of escape of any contained hazardous substances or
contamination by hazardous substances;
 to exclude organisms from a facility;
 to exclude unauthorized people from the facility;
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



5.2
to prevent unintended release of the substances by experimenters working with the
substance;
to control the effects of any accidental release of the substance;
inspection and monitoring requirements; and
qualifications required of the person responsible for implementing the controls.
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1
and those controls in place under other legislation, AgResearch dicyandiamide device
can be adequately contained.
6 Decision
6.1
I have considered this application made under section 31 and, pursuant to section 32, I
am satisfied that this application is for the purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of AgResearch dicyandiamide
device, I am satisfied that the controls imposed, including those in place under other
legislation, will result in the substance being adequately contained.
6.3
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have
applied the criteria specified in section 32.
6.4
I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substances;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
6.5
The containment application to import or manufacture the substance identified as,
AgResearch dicyandiamide device, for the purposes of research and development is
thus approved pursuant to section 32, with controls set out in Appendix 1.
13 August 2007
Rob Forlong
Date:
Chief Executive of ERMA New Zealand
Substance Identifier
ERMA New Zealand Approval Code:
AgResearch dicyandiamide device
HSC000281
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Appendix 1: List of controls that apply to the hazardous
substance AgResearch dicyandiamide device
Scope
1.
This approval covers the contained import or manufacture of a maximum of 100 litres
or kilograms of the substance identified as “AgResearch dicyandiamide device” for field
trialling, as defined in the application.
2.
All lifecycle stages from manufacture to disposal shall be undertaken in accordance
with the information provided by the applicant with their application. Modification of
this information may be approved in writing by ERMA New Zealand providing that it
complies with the following controls.
3.
This approval remains in place for five years from the date of this decision.
4.
Notwithstanding the requirements of control 2, the manufacture and trialling of
AgResearch dicyandiamide device shall also comply with the following controls.
Importation and Transport
5.
The substance shall be transported in compliance with any relevant requirements of
the Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 and the
Maritime Transport Act 1994.
Packaging and information
6.
The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
7.
Packages shall be labelled with the following information:
a.
the unique identifier for the substance; and
b.
the “hazard pictograms” and “hazard statements” for the known hazards of the
substance; and
c.
the signal word “WARNING” followed by the statement “substance may pose
hazards additional to those listed on the label”; and
d.
a list of mitigation measures that should be taken when handling the substance
to limit exposure of people or the environment; and
e.
instruction that any unused quantities of the substance must be returned in its
original container to AgResearch Limited; and
f.
instruction on the correct disposal for the packaging; and
g.
enough detail to contact AgResearch Limited either in person or by telephone.
8.
The information provided on the label shall be provided in a manner compliant with
regulations 32-35 and 36(1)-(7) (inclusive) of the Hazardous Substances (Identification)
Regulations 2001.
9.
A 16 heading layout Safety Data Sheet, compliant with the Hazardous Substances
(Identification) Regulations 2001, shall accompany the substance and be held at the
each trial site during the period of the trial.
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Storage
10.
AgResearch dicyandiamide device shall be stored securely. This may be achieved
through compliance with the Code of Practice for the Management of Agrichemicals
NZS 8409: 2004.
General handling of the substances
11.
Appropriate personal protective equipment (PPE), for example, safety glasses, gloves,
respiratory equipment and protective clothing, shall be worn when handling the
substance during manufacture, use and disposal.
Trial Conditions
12.
The trials may be carried out at locations that have not yet been defined provided that;
prior to the trials commencing, the applicant;
a.
has written permission from the owner of the land to carry out the trials; and
b.
has notified ERMA New Zealand in writing of the locations in accordance with
Control 26.
13.
Access to the trial sites shall be by permission of the Trial Director1, or nominated
researcher.
14.
The trial site boundaries shall be clearly marked and distinctly visible from outside the
trial site for the duration of the trials.
15.
Animals involved in the trials shall be clearly identified as belonging to the trial.
16.
The trial sites shall be signed indicating that unauthorised access is not permitted, that
the site is subject to a trial and that livestock are involved.
17.
During the field trials the substance shall be under the control of experimental staff
who —
a.
are experienced in the handling and application of veterinary medicines under
test conditions using the specified equipment; and
b.
have been made aware of the study protocol and the controls in place in order
to adequately manage the substance and the emergency management
provisions.
18.
Trials shall be conducted in a manner such as to prevent the substance entering surface
or ground water systems.
19.
Livestock involved in the trials shall be subject to any stock withholding periods set by
the ACVM Group of the New Zealand Food Safety Authority.
20.
A record shall be kept of the use of the substance. This record shall cover all matters
referred to in Regulation 6(1) of the Hazardous Substances (Classes 6, 8, and 9
Controls) Regulations 2001 and must be kept for not less than 3 years after the date on
which the substance that the record relates to is applied or discharged.
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of the
trial in accordance with that proposed in the application and the approval controls.
1
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Emergency Management
21.
Any spillage of the substance shall:
a.
be contained and prevented from entering water bodies; and
b.
be absorbed with an appropriate absorbent material where appropriate. The
absorbent material shall be placed in sealed containers and disposed of
appropriately.
Disposal
22.
Any surplus substance remaining at the end of the trials shall be stored in an exempt
laboratory that meets the requirements set out in the Hazardous Substances (Exempt
Laboratories) Regulations 2001 for the purpose of further analysis or until disposed of.
23.
Where disposal of the substance is required it shall be disposed of in a manner
compliant with the Hazardous Substances (Disposal) Regulations 2001.
24.
Packaging no longer used to contain the substance or residue or rinsate from
equipment used to handle the substance shall be disposed of in a manner compliant
with the Hazardous Substances (Disposal) Regulations 2001.
Notification and inspection
25.
26.
27.
The Department of Labour [Attn. HSNO Project Manager (Workplace Group) or
equivalent position] and ERMA New Zealand shall be informed in writing (by letter,
fax or email) of the location, start, and completion of the trials. Notifications shall
include the following details:
Substance name
ERMA Application number
AgResearch dicyandiamide device
HSC07017
ERMA Approval number
HSC000281
ERMA Applications Advisor
Brendon Noonan
If for any reason a breach of containment occurs, the Trial Director shall:
a.
notify the Department of Labour and ERMA New Zealand within 24 hours of
the breach being detected;
b.
advise the relevant iwi authority, if the breach of containment results in the
contamination of a waterway.
The Authority, or its authorised agent, or properly authorised enforcement officers,
may inspect the facilities and trial sites at any reasonable time. Trial documentation, as
described in Control 2, notwithstanding its confidential nature, shall be available for
inspection by any enforcement officer, upon request.
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